Date: 17-Aug-2020

Maharashtra FDA Submits Reports About Adequate Availability Of HCQ, Remdesivir And Tocilizumab Injections To CDSCO

The Maharashtra FDA has submitted reports about adequate availability of hydroxychloroquine (HCQ) tablets, remdesivir and tocilizumab injections to the Central Drugs Standard Control Organisation (CDSCO) for monitoring and compliance.

According to data shared by the state FDA with the CDSCO, there is stock of 39,60,662 HCQ tablets, 21,473 remdesivir and 1,249 tocilizumab injections at government hospital based pharmacies and with private retailers and stockists till date. Maharashtra FDA has acknowledged that there is adequate stock of essential medicines both in government hospital pharmacies and also in retailer pharmacies across the state.

As per Union health ministry, sale of these drugs should be strictly dispensed on the prescription of a registered medical practitioner (RMP). Hence, the state drug regulator has issued circulars to the pharmacies in the state to not sell these drugs without a valid prescription. HCQ drug is a Schedule H1 drug and retailers/wholesalers have to mandatorily maintain the record of sale and purchase.

In order to ensure that adequate stock of essential drugs are available at most of the hospital based pharmacies and leading medical stores in Maharashtra. Maharashtra FDA has started 24x7 control room at its Mumbai head office for reporting issues related to unavailability of essential drugs through its toll free number 1800222365 and 022 26592362/ 26592263/ 26592365. HCQ production in the country has increased from 12.23 crore during the lockdown period to 30 crore per month. The country has also released about 16 crore tablets of HCQ to Central and State institutions as well as pharmacies against requirement of about 2.5 crore tablets in the past.

HCQ is an anti-malarial drug commonly used to treat rheumatoid arthritis, lupus and malaria. It decreases pain and swelling in arthritis patients. The drug has shot to popularity with clinical trials underway globally to investigate its possible use in treating the COVID-19 infected patients and also its use as a prophylactic medicine for COVID-19.

On April 1, 2020, the Centre made it mandatory for chemists to sell the medicine with doctor’s prescription only by including HCQ drug under Schedule H1 category. In a notification on March 25, 2020, the government placed HCQ on a restricted items list and then put a blanket ban on any export of the drug on April 4, 2020. It later on revoked the ban on April 6, 2020, effectively overturning the previous notification.

Schedule H1 was introduced by the Centre through Gazette notification dated August 30, 2013 to check indiscriminate use of antibiotics, anti-TB and some other drugs in the country.